Added
26 days ago
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Type
Full time
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Salary not provided
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Related skills

gcp project management regulatory affairs translation management regulatory compliance

📋 Description

  • Lead global site start-up activities and strategy.
  • Manage ICF customization and IRB/EC submissions.
  • Deliver IMP release packages with QA checks.
  • Serve as SME and trainer for country start-up teams.
  • Coordinate translations for submission documents.
  • Track milestones and monitor progress across study/site.

🎯 Requirements

  • Bachelor's in life sciences or RN; 5+ years site start-up.
  • 5+ years site start-up across multiple countries (CRO/pharma).
  • 2+ years project milestone management, resources, budgets.
  • Strong leadership and cross-functional collaboration.
  • Fluent in English; local language for non-English countries.
  • Knowledge of GCP/ICH guidelines and regulatory requirements.
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